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The Effect of Mild Weight Loss on Circulating Metabolite Profiles

Metabolomics Identifies Increases in Acylcarnitine Profiles in Plasma of Overweight Subjects in Response to Mild Weight Loss

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135132
Enrollment
100
Registered
2017-05-01
Start date
2015-06-30
Completion date
2016-10-31
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visceral Fat, Weight Loss

Keywords

High visceral fat, Low calorie diet, Mild weight loss, Metabolomics, Metabolites, Acylcarnitines

Brief summary

To determine whether low calorie diet (LCD)-induced weight reduction caused changes in plasma metabolites and metabolic traits from baseline.

Detailed description

Over a 12-week clinical intervention period, a randomized, controlled study was carried out; overweight subjects consumed a LCD (approximately 300kcal/d deficit, n=47) or a weight-maintenance diet (control, n=50) were included for analyzing plasma samples and metabolites using an ultra-performance liquid chromatography and mass spectrometry (UPLC-LTQ/Orbitrap MS).

Interventions

BEHAVIORALControl group

Recommend to consume usual diet during 12-week study period

BEHAVIORALLCD group

Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Able to give informed consent * 20-65 years old * Males and females * Overweight (25.0 kg/m²≤ Body mass index \<30 kg/m²) * Nondiabetic (Fasting glucose \<126 mg/dL)

Exclusion criteria

* Unstable body weight (body weight change \>1 kg within 3 months before screening) * Consumption of medication that affects body weight or energy expenditure * Pregnancy or breast-feeding * Hypertension, type 2 diabetes, cardiovascular disease, cerebrovascular disease, or thyroid disease * Liver disease, kidney disease, or gastrointestinal disease * Acute or chronic infections * Any acute or chronic disease requiring treatment

Design outcomes

Primary

MeasureTime frame
Visceral fat area at L4 (CT)At baseline
Change in visceral fat area at L4 from baselineAt baseline and 12-week follow-up
Putatively identified plasma metabolites (Normalized peak intensities)At baseline
Changes in putatively identified plasma metabolites (Normalized peak intensities) from baselineAt baseline and 12-week follow-up

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026